Liver Cirrhosis
Conditions
Keywords
Liver Cirrhosis, Mesenchymal Sem Cells
Brief summary
There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients. This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.
Interventions
PROCEDUREmesenchymal stem cell transplantation via peripheral vein
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
OTHERmesenchymal stem cell
mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blind to the randomization results of the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-65 years 2. HBV -related liver cirrhosis 3. Child-Pugh score ≥7 4. With presentations of decompensation 5. Written consent
Exclusion criteria
1. Hepatocellular carcinoma or other malignancies 2. Severe problems in other vital organs(e.g.the heart,renal or lungs) 3. Pregnant or lactating women 4. Severe bacteria infection 5. Anticipated with difficulty of follow-up observation 6. Coinfection with HIV or other viral hepatitis. 7. Drug abuse or alcohol abuse 8. History of severe allergy to biological products 9. Other candidates who are judged to be not applicable to this study by doctors -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Change of liver functions as assessed by MELD score | 1 year | Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43) |
| Safety: Adverse events as assessed according to CTCAE 4.03 | 1 year | Adverse events as assessed according to CTCAE 4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival Benefit: Survival Rate at different time points | 1 year, 2 year and 5 years | survival rate at different time points |
| Histological change of the liver: Histological scores assessed by liver biopsy | 1 year, 2 year and 5 years | histological scores assessed by liver biopsy at baseline and after treatment |
| Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy | 1, 2 and 5 years | Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy |
Countries
China
Contacts
Primary ContactChangcun Guo, MD
Outcome results
None listed